FDA Inspection
Atlas Analytical Inc.Atlas Analytical Inc. – FDA Inspection, Nov 14, 2019
Record Details
This FDA Inspection record concerns Atlas Analytical Inc., with an inspection on November 14, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Atlas Analytical Inc.
- Inspection Date
- November 14, 2019
- Product Type
- Drugs
View Company Profile
ID · caefb21b-ea9a-4398-939e-a399e1d9130b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1110013
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.